Table 6 Harms analysis populations in 69 trials that presented harms analyses
From: Nonadherence to treatment protocol in published randomised controlled trials: a review
| Â | Number (%a) | |
|---|---|---|
Harms analysis population specifically defined in methods | 26 (38) | |
Defined harms analysis population | Based on actual treatment received (that is, including all patients who had received at least one administration of treatment) | 18 |
| Â | Intention to treat | 5 |
| Â | All who started allocated treatment | 2 |
| Â | All who completed allocated treatment | 1 |
Harms analysis population not specifically defined in methods | 43 (62) | |
Inferred harms analysis population | Stated ‘safety population’ without further definition | 1 |
| Â | Apparently analysed as per efficacy outcomes | 33 |
| Â | Intention to treat definition | 31 |
| Â | Per protocol definition | 2 |
| Â | No details given of harms or benefit analysis population | 9 |